Prevention & lipidsRandomised controlled trial
Inclisiran-based treatment strategy in hypercholesterolaemia: the VICTORION-difference trial
- Randomised controlled trial
- phase 4
- double-blind
- placebo-controlled
Authors' conclusion
An inclisiran-based treatment strategy was superior to ioLLT in LDL-C goal achievement, delivering early and sustained LDL-C reduction, with fewer MRAEs in individuals with hypercholesterolaemia.
Study context
- Population
- Adults with hypercholesterolaemia at high or very high cardiovascular (CV) riskmean age 63.7 years
- Participants
- 1,770 adults
- Comparison
- Inclisiran + individually optimized lipid-lowering therapy (ioLLT) vs placebo + ioLLT
- Inclisirann = 898
- ioLLTn = 872reference
- Primary endpoint
- Achievement of individual low-density lipoprotein cholesterol (LDL-C) goal
- Follow-up
- Day 90
Primary result
Individual LDL-C goal achieved
Odds ratio
12.09
P < 0.001
By group
As reported in the abstract
Secondary outcomes
Mean
| Outcome | Inclisiran | ioLLT | least squares mean treatment difference | P value |
|---|---|---|---|---|
| Mean % reduction in LDL-C from baseline · Day 360 | −59.5% | −24.3% | −35.14% | P < 0.001 |
| Short Form-Brief Pain Inventory pain severity and interference scores · pain severity | −0.11 | P = 0.039 | ||
| Short Form-Brief Pain Inventory pain severity and interference scores · pain interference | −0.11 | P = 0.029 |
Safety
Muscle-related adverse events (MRAEs)
OR 0.57 · P < 0.001
Muscle-related adverse events (MRAEs)
- No new safety concerns identified
Original publication
Inclisiran-based treatment strategy in hypercholesterolaemia: the VICTORION-difference trial. Eur Heart J. Published 30 August 2025. doi:10.1093/eurheartj/ehaf685
Summarised from the published abstract; every number is checked against it